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Medical Device Technical File

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What is Technical File?

The technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to demonstrate that the product conforms to the applicable and current medical device regulations.

Technical files for medical devices shall include, e.g. a detailed description of the device and specification, reference to the previous and similar generation of the device, design information, pre-clinical testing information, clinical evaluation, and risk management of the medical device.

Technical file for medical devices shall be prepared by the medical device manufacturer and the information’s in the technical file or technical file for medical devices must be presented in a clear, organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the medical device in question.

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Medical Device Technical File (MDR)

Want to prepare a medical device technical file as per the requirement of MDR 2017/745? If your answer is yes, you probably have lots of questions about the preparation of medical device technical files such as;

  • What shall be covered in the medical devices technical file?
  • Which Annex of -MDR 745/2017 shall be referred for the preparation of medical device technical file according to MDR?
  • Who will review and approve the medical device technical file?

We at Maven Profcon Services LLP, shall give you all the answers.

Medical device technical file shall be prepared as per the requirement of Annex II and Annex III of MDR 2017 / 745.

The technical file shall be submitted to the notified body or competent authority for review and approval for CE Certification. It should be made in the English language or the official language of an EU member state.

Under the MDR, the manufacturer shall safely store the technical documents for 10 years other than implantable device after the last device has been placed on the market, and in case of the implantable device, it should be safely stored for 15 years and non-EU manufacturer documents should be available with the Authorized Representative also.

Medical device manufacturers should be responsible for keeping the technical file up to date and in compliance with general safety and performance requirements Annex I, Annex II, and Annex III of MDR 2017/745.

Technical File content

Sr. No. Section Description
Section 1 General and Administrative Information.
1. 1.0 Table of Content
2. 1.1 Technical file approval team
3. 1.2 General information for the Technical file structure including purpose, scope
4. 1.3 Company Profile
5. 1.3.1 Legal Name & Address of the Manufacture
6. 1.4 Authorized Representative name, address and contact details
7. 1.5 Notified Body Name, Number and Address
Section 2 Technical Documentation
8. 2.1 Device Description And Specification, Including Variants And Accessories
9. 2.1.1
  • Device description and specification
  • Product name or trade name
  • General Description of Device
  • Intended Purpose
  • Indication of use
10. 2.1.1.1
11.
12.
13.
14. 2.1.1.2 Basic UDI-DI
15. 2.1.1.3 Intended patient populations, including details of if applicable;

  • Medical Condition to be diagnostic, treatment, or monitoring
  • Patient selection criteria
  • Indication
  • Contraindications
  • Warning
16. 2.1.1.4 Principle of operation including mode of action
17. 2.1.1.5 Rational for considering the product as medical device
18. 2.1.1.6 Device Classification and Justification for the classification rule as per Annex VIII
19. 2.1.1.7 Explanation of Novel Features
20. 2.1.1.8 Description of Accessories of device
21. 2.1.1.9 A Description of various configurations/variants
22. 2.1.1.10 General description of key components for including software where appropriate required add photograph, drawing and Diagram
23. 2.1.1.11 Description of Raw Materials
24. 2.1.1.12 Technical Specification like feature, dimension
25. 2.2 Reference of Previous and Similar Generations of the device
26. 2.3 Information Supplied by the Manufacturer
27. 2.3.1 Labels: Primary Label, Secondary label and Tertiary label

If you are selling device require specific county language then label should be available on that language

28. 2.3.2 Instruction for use (IFU)

If you are selling device require specific county language then IFU should be available on that language

29. 2.4 Design and Manufacturing Information
30. 2.4.1 Product design File
31. 2.4.2 Manufacturing process and their process validations
32. 2.4.3 Final Product Specification & Testing
33. 2.4.4 Manufacturing Environment Control
34. 2.4.5 Identified the sites including supplier & subcontractors, where design activates are performed
35. 2.5 General Safety & Performance Requirements (GSPR)
36. 2.5.1 List of Applicable Harmonized Standards, Common Specification (CS), Non-harmonized standards, applicable guidelines
37. 2.5.2 General Safety & Performance Requirements (GSPR)
38. 2.5.3 Declaration of Conformity
39. 2.6 Benefit and Risk Analysis & Risk Management
40. 2.7 Product Verification and Validation
41. 2.8 Pre-clinical and Clinical Data
42. 2.8.1 Pre-clinical and Clinical summary report
43. 2.8.2 Biocompatibility of the device
44. 2.8.3 Electrical Safety and compatibility
45. 2.8.4 Physical, Chemical & Microbiological Compatibility
46. 2.8.5 Software Verification and Validation
47. 2.8.6 Stability or self-life
48. 2.8.7 Sterilization
49. 2.8.8 Performance & Safety
50. 2.8.9 Clinical Evaluation Report
51. 2.8.10 Post Marketing Activities

  • PMCF Plan & Report
  • PSUR Report
  • PMS Plan & Report
  • Tread Reports
52. 2.8.11 Packaging & Transportation information
53. 2.9 Additional Information is required in specific case:
54. 2.9.1 When device incorporate a substance consider separately as medicine
55. 2.9.2 Device is manufactured by using tissue or cells of human or animal origin
56. 2.9.3 Device that are composed of substance or combination of substance
57. 2.9.4 CMR or Endocrine-Disrupting Substance
58. 2.10 Detail of Device with measuring function
59. 2.11 Details of the device to be connected to other device to achieved its intended purpose
60. 2.12 Revision History
61. 2.13 Conclusion & Approval

Consultant for Technical Documentation

Our regulatory consultants in Maven who are experienced in various fields of Medical Device Regulations are well versed in taking care of technical documentation like clinical evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering file, safety and biological evaluation, and chemical characteristics evaluation.

Our regulatory consultants help you in identifying requirements as per EU MDR, identification of CE assessment route according to the class of the device, helps in clinical evaluation and also in post-marketing activities, risk analysis, and quality management implementation.

Maven as a developing medical device regulatory consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The below mentioned activities are taken care by us

  • Gap analysis of Medical Device Technical file as per the requirement of EU-MDR
  • Identification and classification of the medical device as per EU MDR
  • Help in selection of conformity route of assessment and Notified body
  • Preparation and Review of the technical documents as per EU MDR.
  • Help to maintain and update the technical file post certification.

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